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The Translational Research Working Group developmental pathway for anticancer agents (drugs or biologics)
Richard L Schilsky1, Gary Gordon, Tona M Gilmer
1University of Chicago, Chicago, Illinois, USA.
Abstract:
The Translational Research Working Group (TRWG) was created as a national initiative to evaluate the current status of the National Cancer Institute's investment in translational research and envision its future. The TRWG conceptualized translational research as a set of six developmental processes or pathways focused on various clinical goals. One of those pathways describes the development of agents-both small molecules and biologics-for the treatment and prevention of cancer. The Agents Developmental Pathway was conceived not as a comprehensive description of the corresponding real-world processes, but rather as a tool designed to facilitate movement of an agent through the translational process to the point where it can begin definitive clinical testing. This article presents the Agents Developmental Pathway and discusses key challenges associated with the processes described.
Insights
The Translational Research Working Group (TRWG) developed an Agents Developmental Pathway to advance cancer treatments. This framework aids in moving therapeutic agents from discovery to clinical trials, addressing key challenges in cancer research.
Area of Science:
- Oncology
- Translational Research
- Drug Development
Background:
- The National Cancer Institute established the Translational Research Working Group (TRWG) to assess and shape its investment in translational research.
- Translational research is crucial for bridging laboratory discoveries with clinical applications in cancer treatment.
Purpose of the Study:
- To present the Agents Developmental Pathway, a key component of the TRWG's conceptualization of translational research.
- To outline the processes involved in developing therapeutic agents for cancer treatment and prevention.
Main Methods:
- Conceptualization of translational research as six developmental pathways.
- Focus on the Agents Developmental Pathway, detailing the progression of small molecules and biologics.
- Identification of critical challenges within the agent development process.
Main Results:
- The TRWG defined translational research pathways, including one for agent development.
- The Agents Developmental Pathway serves as a tool to streamline the progression of therapeutic agents.
- Key challenges in agent development were identified and discussed.
Conclusions:
- The Agents Developmental Pathway provides a structured approach to cancer agent development.
- Addressing identified challenges is essential for efficient translation of cancer therapies.
- This pathway facilitates the movement of agents toward definitive clinical testing.
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